RightFit
RecruitingPhase 3

Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Revumenib in Combination With Intensive Chemotherapy in Participants With Newly Diagnosed AML With an NPM1 Mutation

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether adding revumenib to standard chemotherapy works better than chemotherapy alone and is safe. It is for people with newly diagnosed acute myeloid leukemia (AML), a blood cancer, who have an NPM1 gene change and can receive strong chemotherapy.

The purpose of this study is to assess if adding revumenib to standard chemotherapy improves outcomes in participants with AML with certain genetic mutations compared to chemotherapy alone. The study will also assess the safety of adding revumenib to chemotherapy.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have newly diagnosed AML that has not been treated, and be able to receive strong chemotherapy.
  • Have an NPM1 gene change.
  • Meet daily activity score limits: ECOG 2 or less (1 or less if over 65), and Karnofsky or Lansky 40 or more.
  • Be expected by the study doctor to live at least 3 months.
  • Have a negative blood pregnancy test.
  • Have liver, kidney, and heart function that meets study requirements.

Who can't join

  • Have active acute promyelocytic leukemia, a type of AML.
  • Have active disease in the brain or spinal cord.
  • Have a heart rhythm test result called QTcF over 450 milliseconds, known or suspected long QT syndrome, or a family history of this heart rhythm condition.
  • Have a problem in the upper digestive tract that could affect taking or absorbing medicine by mouth.
  • Have another cancer that needs active treatment, except breast or prostate cancer that is stable or improving with hormone treatment.
  • Cannot swallow medicine.
  • Are pregnant or breastfeeding.
  • Have active or long-term hepatitis B, active hepatitis C, or HIV with virus levels that can be detected in the blood.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Key Inclusion Criteria: * Participants must have newly diagnosed and previously untreated AML and be candidates for intensive chemotherapy. * Presence of an NPM1 mutation. * Eastern Cooperative Oncology Group performance status ≤2 (≤1 if \>65 years old); Karnofsky or Lansky ≥40. * Have a life expectancy of ≥3 months as judged by the Investigator. * Negative serum pregnancy test. * Adequate liver, kidney, and cardiac function. Key Exclusion Criteria: * Diagnosis of active acute promyelocytic leukemia. * Active central nervous system disease. * Fridericia's corrected QT interval (QTcF) \>450 milliseconds at screening, diagnosis or suspicion of Long QT syndrome or family history of Long QT syndrome. * Any gastrointestinal (GI) issue of the upper GI tract likely to affect oral drug absorption or ingestion. * Any concurrent malignancy requiring active therapy (except breast or prostate cancer stable on or responding to endocrine therapy). * Inability to swallow oral medication. * Pregnant or nursing females. * Participant has known active or chronic hepatitis B or active hepatitis C (HCV) infection or human immunodeficiency virus (HIV)-positive with detectable viral load. Note: Additional inclusion/exclusion criteria may apply, per protocol.

Study sites (6)

AZ

CA

IN

LA

RI

TX